FOOTNOTES
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NHRPAC Takes Actions Vital to Social Science

At its January 28-29, 2002 Meeting, the National Human Research Protections Advisory Committee (NHRPAC) dealt with four issues—public use data files, third parties, risk and harm, and confidentiality—of critical importance to the social and behavioral sciences. All four were topics that have engaged the attention of NHRPAC’s Social and Behavioral Science Working Group (SBS), co-chaired by ASA Executive Officer Felice Levine. (Levine is a member of NHRPAC.)

With unabashed enthusiasm, Levine gave a thumbs-up, calling these decisions “five star.” “NHRPAC is a diverse group of persons knowledgeable about and deeply committed to advancing human research protections and research,” Levine said, “That this group came together after months of hard effort and reached strong consensus on such important issues affirms the significance of these recommendations and also that the concerns of social science are very much on the ‘page.’”

NHRPAC is appointed by the Secretary of Health and Human Services (HHS) to advise the Secretary and the Director of the Office of Human Research Protections (OHRP) on the protection of human research subjects and the operations of the human subjects protection system. NHRPAC issues reports and recommendations to the HHS Secretary and OHRP Director for their consideration. As a high-profile advisory committee, NHRPAC’s expert advice and recommendations are likely to be given due consideration.

Public Use Data Files

Heading the list of NHRPAC actions in January was a series of recommendations on Public Use Data Files. Increasingly over the past few years, institutional review boards (IRBs) at many institutions have been reviewing protocols when investigators used data files already available for public use (e.g., the General Social Survey, the Panel Study of Income Dynamics, Census data). Obtaining additional IRB approval has had major consequences for research and teaching.

As reported in January Footnotes, NHRPAC, at its October meeting, approved in principle a set of recommendations on public use files advanced by its SBS Working Group. The essence of these recommendations was that data sets reviewed and approved by IRBs as de-identified and ready for public use do not need further review by other IRBs prior to use.

Over the last several months, a NHRPAC subcommittee headed by Levine crafted a set of recommendations that makes clear to IRBs and others what public use data files are, that producers and suppliers of data sets are responsible for having them reviewed by IRBs before making them publicly available, and that, once certified as public use files, no additional review by IRBs is required. Also, recommendations addressed how IRBs can make the determination that data files can be classified as public use. At its January meeting, NHRPAC reviewed these recommendations and gave its official approval. While these recommendations are particularly important to the social and behavioral sciences, they are applicable to all public use data files.

Third Parties

NHRPAC also took official action on the issue of third parties. The topic surfaced on the agenda of NHRPAC and the SBS Working Group last March after the Virginia Commonwealth University case brought the topic to the public’s attention. Since that time, there has been considerable debate about the status of persons referenced by human subjects in the course of their interaction with investigators. There was ready agreement that all information in identifiable form—whether about human subjects or others they reference—must be given the highest possible protection from disclosure. The debate, however, concerned when or whether these third parties were themselves human subjects.

Formal and informal federal agency committees also weighed in and yet, at times, agreement seemed remote. Although the dust may or may not have completely settled on the issue, at its January meeting, NHRPAC agreed, in concept and language, on a one-page statement of clarification as to the status of third parties. These recommendations are to be advanced to the Secretary of HHS and to the Director of the Office of Human Research Protections.

The NHRPAC statement makes clear that the determination of who is a research subject rests with the IRB; third parties who are referenced in research are not necessarily considered human subjects; and, third parties may become human subjects if they can be identified and if the IRB, through careful analysis of a number of factors, determines that the focus of the research is really on the third party and not on (or not only on) the originally designated human subject. NHRPAC’s recommendations on third parties are critically important. They clarify the status of information provided by human subjects about someone else (i.e., third parties) and make clear that the requirement of consent, or waiver of consent, pertains only to human subjects and not to third parties unless IRB’s determine that these third parties are subjects as well.

Risk and Harm

In addition to NHRPAC completing its work and advancing recommendations on public use data files and third parties, it also advanced recommendations to the next stage of approval for risk and harm and for confidentiality.

The SBS Working Group first advanced a report and recommendations on risk and harm to NHRPAC in July 2001. Because of other priority issues, including the two topics above, risk and harm was only briefly considered at prior meetings of NHRPAC. At its January 2002 meeting, the statement was thoroughly discussed and positively received. Two major categories of recommendations met with NHRPAC’s support: (1) clarification of “minimal risk” (including teasing apart two conflated concepts—the probability and magnitude of harm, as well as providing clearer guidance regarding the application of the “daily life” standard); and, (2) examination of expedited review categories and creation of best practices for the timeliness of expedited review. Also, NHRPAC responded positively to the report’s emphasis on the fact that affirmative steps can be taken to ameliorate risks across areas of research. Accepting the Working Group’s recommendations in principle, NHRPAC will be crafting final language for its review and approval.

Confidentiality

In January, NHRPAC also accepted in principle a report and recommendations prepared by the SBS Working Group on “Issues in Confidentiality and Research Data Protections.” The recommendations, spanning five topic areas, aim to: (1) convey to IRBs that the degree of confidentiality protection required in research should be commensurate with the degree of risk, while allowing a good data protection plan to reduce or eliminate the risk; (2) encourage OHRP to examine existing confidentiality protections in certificates of confidentiality offered by federal agencies and in various statutes; (3) encourage OHRP to provide guidance to IRBs and investigators regarding limitations in confidentiality protections and how this information can be conveyed effectively during the consent process; (4) emphasize the research institution’s role in supporting investigators’ attempts to protect confidential information from compelled disclosure; and (5) clarify for IRBs and investigators that when identifiable data are shared between investigators, the original confidentiality protections are transferred with the data.

NHRPAC will be preparing a final set of recommendations based on comments from its members. With considerable enthusiasm for the substance of the report, NHRPAC members underscored its applicability to all areas of research, not just to social and behavioral science research.

Next Steps

Executive Officer Levine will chair subcommittees of NHRPAC crafting the final editions of the risk and harm as well as confidentiality recommendations. The efforts of the Social and Behavioral Science Working Group to identify areas in the human subjects protection system that can operate more efficiently and effectively have been well-received by NHRPAC. Informed consent is actively on the agenda of the SBS Working Group and of NHRPAC. The Working Group is in the process of setting its next priorities with benefit of input from the social and behavioral science community. The goal is to ensure protections for research participants without unnecessarily restricting scientific pursuits or the training of new investigators.

As Footnotes goes to press, the NHRPAC recommendations on Public Use Data Files and Third Parties are about to be formally transmitted to the Secretary of Health and Human Services. They are also being posted on NHRPAC’s website at http://ohrp.osophs.dhhs.gov/nhrpac/nhrpac.htm. Interested readers should check this website regularly as well as the website for the SBS Working Group at http://www.asanet.org/public/humanresearch/. The SBS Working Group welcomes comments on all reports and draft recommendations posted on their website as well as general comments or concerns. The work of all NHRPAC Working Groups is important input and advice to NHRPAC as it executes its official duties as a Federal advisory committee.